NCT06980142

A Study of CM512 in Subjects With Moderate-to-Severe Chronic Obstructive Pulmonary Disease

A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating CM512 Injection in Subjects With Moderate-to-Severe Chronic Obstructive Pulmonary Disease

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 204 (estimated)
• Sponsor: Keymed Biosciences Co.Ltd · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase II Study to Explore the Efficacy and Safety of CM512 Injection in Adults with Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)

Detailed description

This is a Phase II, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of CM512 in adults with moderate-to-severe chronic obstructive pulmonary disease (COPD) receiving triple or double inhaled maintenance therapy, and having had 1 or more documented COPD exacerbations in the 12 months prior to Visit 1. Subjects will receive CM512, or placebo, administered via subcutaneous injection at the study site, over a 52 week treatment period. The study also includes a post-treatment follow-up period of 12 weeks.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
BIOLOGICAL	CM512	Administered SC
DRUG	Placebo	Administered SC

Timeline

• Start date: 2025-06-20
• Primary completion: 2028-03-17
• Completion: 2028-03-17
• First posted: 2025-05-20
• Last updated: 2025-05-20